BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXICAP

    MDR report key: 2931495 · Received January 28, 2013

    Report

    Report Number
    1416980-2013-02062
    Event Type
    Injury
    Date Received
    January 28, 2013
    Date of Event
    December 1, 2012
    Report Date
    January 3, 2013
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K972579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE IS NOT AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 4 OF 4 INVOLVED IN THIS PERITONITIS EVENT

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT CANNOT BE CONFIRMED AS NO SAMPLES ARE AVAILABLE, THE ASSIGNABLE CAUSE IS UNDETERMINED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A CONSUMER WITH SUPPLEMENTAL INFORMATION PROVIDED BY A NURSE IN THE USA OF PT (PATIENT) MADE MISTAKE/TOUCH CONTAMINATION, INCARCERATED HERNIA, AND REFRACTORY PERITONITIS WITH CULTURE POSITIVE FOR GRAM POSITIVE ORGANISM IN A FEMALE PATIENT (BORN IN 1963) COINCIDENT WITH DIANEAL PD4 AMBUFLEX AND DIANEAL PD4 ULTRABAG THERAPIES.ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX THERAPY (LOT NUMBER, DOSE AND FREQUENCY NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DIANEAL THERAPY WAS ONGOING. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE, THE PATIENT MADE MISTAKE/TOUCH CONTAMINATION. ON (B)(6) 2013, THE PATIENT EXPERIENCED PERITONITIS. ON (B)(6) 2013, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. THE TREATMENT FOR THE EVENT WAS NOT REPORTED. CAUSE OF PERITONITIS WAS PT MADE MISTAKE/TOUCH CONTAMINATION. THE OUTCOME FOR THE PATIENT MADE A MISTAKE/TOUCH CONTAMINATION WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE PERITONITIS. FOLLOW-UP INFORMATION ((B)(6) 2013): FURTHER INFORMATION WAS RECEIVED FROM A NURSE, WHO MEDICALLY CONFIRMED THIS REPORT. DIANEAL PD4 ULTRABAG WAS ADDED AS A SUSPECT PRODUCT. PERITONITIS WAS AMENDED TO REFRACTORY PERITONITIS WITH CULTURE POSITIVE FOR GRAM POSITIVE ORGANISM. INCARCERATED HERNIA WAS ADDED AS AN EVENT.ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 ULTRABAG THERAPY (DOSE, FREQUENCY, AND LOT NUMBER NOT REPORTED) IP FOR PD. DIANEAL THERAPY WAS ONGOING. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED INCARCERATED HERNIA. ON (B)(6) 2012, THE PATIENT EXPERIENCED REFRACTORY PERITONITIS AND WAS HOSPITALIZED ON THE SAME DAY. TREATMENT FOR THE EVENTS WAS NOT REPORTED. PER NURSE, THE INCARCERATED HERNIA CAUSED REFRACTORY PERITONITIS. THE OUTCOME FOR THE EVENT OF PATIENT MADE A MISTAKE/TOUCH CONTAMINATION AND INCACERATED HERNIA WAS NOT REPORTED. AT THE TIME OF REPORT, THE PATIENT WAS RECOVERING FROM THE EVENT OF PERITONITIS. AN OPINION OF CAUSALITY OF WAS NOT PROVIDED FOR THE EVENT OF THE PATIENT MADE A MISTAKE/TOUCH CONTAMINATION AND INCARCERATED HERNIA. PER THE NURSE, THE EVENT OF REFRACTORY PERITONITIS WAS UNRELATED TO DIANEAL THERAPY. PRODUCT SURVEILLANCE MADE CONTACT WITH THE PERITONEAL DIALYSIS (PD) NURSE ON (B)(6) 2013 REGARDING THE REPORTED INCIDENT OF THE HERNIA. THE NURSE REPORTED IT IS UNKNOWN HOW LONG THE PATIENT HAS HAD AN UMBILICAL HERNIA. AT THIS TIME THE PATIENT HAS A REFRACTORY PERITONITIS CAUSED BY THE INCARCERATED HERNIA. THE PD NURSE DENIED THAT THE PATIENT EXPERIENCED A STRANGULATED BOWEL DUE TO THE HERNIA. PD THERAPY HAS BEEN TEMPORARILY DISCONTINUED AND THE PATIENT IS USING HEMO-DIALYSIS THERAPY. THE PATIENT IS BEING TREATED WITH ANTIBIOTICS (NAME, DOSE, ROUTE, FREQUENCY ARE UNKNOWN). WHEN ANTIBIOTIC THERAPY IS COMPLETED, THE PATIENT WILL UNDERGO A SURGICAL REPAIR FOR THE UMBILICAL HERNIA, RECOVER FOR APPROXIMATELY 4 WEEKS, AND THEN RETURN TO PD THERAPY. THE PD NURSE DENIED THE PATIENT HAS EXPERIENCED ANY OVERFILL (IIPV) EVENTS FOR THIS PATIENT. THE HOMECHOICE WILL BE RETURNED TO BAXTER AS THE PATIENT IS ON BACK-UP HEMODIALYSIS AT THIS TIME. AFTER THE PATIENT IS CONSIDERED TO BE RECOVERED FROM THE SURGICAL REPAIR OF THE HERNIA, A NEW HOMECHOICE DEVICE WILL BE REQUESTED FOR THE PATIENT TO RETURN TO USING PD THERAPY (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38066 FLEXICAP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R DIANEAL PD4 AMBUFLEX| HOMECHOICE| DIANEAL ULTRABAG